Revision Breast Reconstruction with Prepectoral Pocket Conversion of Submuscular Breast Implants.
Franca Kraenzlin, Karan Chopra, George Kokosis...
https://pubmed.ncbi.nlm.nih.gov/33890886Actively Recruiting
Age: 18Years - 70Years
FEMALE
ID07037576
Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
Led by Henan Cancer Hospital · Updated on 2025-06-25
104
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of two types of breast reconstruction in women with breast cancer who need postoperative radiotherapy. It focuses on comparing immediate one-stage prepectoral prosthetic reconstruction with two-stage expander/prosthesis reconstruction in patients diagnosed with breast cancer without distant metastasis. The study will record changes in quality of life using BREAST-Q scores, as well as complications, capsular contracture, and tumor safety over time. Participants will undergo nipple-sparing or skin-sparing mastectomy followed by either immediate prepectoral implant reconstruction or two-stage reconstruction involving a tissue expander first, then permanent implant after radiotherapy. Both surgical approaches allow open, endoscopic, or robotic techniques, with or without mesh use. Radiotherapy timing differs: immediate reconstruction patients receive radiotherapy after implant placement, while two-stage reconstruction patients receive radiotherapy with the expander in place before implant exchange six or more months later. Throughout the study, patients will be monitored with quality of life assessments before surgery and one year afterward using BREAST-Q scores. Secondary outcomes include breast reconstruction success rates, surgical complications, aesthetic evaluations by doctors, capsular contracture development, nipple and skin sensation, and long-term tumor safety measured by disease-free and overall survival up to five years. The study plans to enroll over 104 patients, with participation lasting at least one year for primary outcomes and longer for survival follow-up.
CONDITIONS
Brief Title
Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
Who Can Participate
Age: 18Years - 70Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Newly diagnosed breast cancer patients with no distant metastasis
- Require adjuvant radiotherapy
- Scheduled for nipple-sparing or skin-sparing mastectomy with immediate prepectoral implant reconstruction or two-stage expander/implant reconstruction
- Mesh use in reconstruction surgery allowed
- Severe breast ptosis allowed
- Lipofilling and contralateral breast symmetrization permitted during observation
- ECOG performance status 0-1
- Patients receiving neoadjuvant chemotherapy allowed
- Bilateral breast reconstruction permitted
- No smoking history or quit smoking at least 4 weeks before enrollment
- Confirmed ability to comply with protocol
- Concurrent participation in other trials allowed if non-interfering
- Voluntary informed consent given
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- No prior radiotherapy after mastectomy
- History of ipsilateral chest wall or axillary radiation therapy
- Immunodeficiency, poorly controlled diabetes (HbA1c >7%), or active tobacco use
- Inflammatory breast cancer (cT4d)
- Autologous or delayed breast reconstruction
- Severe cardiopulmonary, hepatic, or renal diseases contraindicating surgery or radiotherapy (ASA class ≥III)
- Psychiatric disorders preventing independent BREAST-Q completion
- Pregnancy or breastfeeding
- History of protocol non-adherence
- Life-limiting comorbidities interfering with treatment or investigator-determined ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Breast Reconstruction Surgery
Duration - Surgery and postoperative radiotherapy period
Participants undergo immediate one-stage prepectoral prosthetic breast reconstruction or two-stage expander/implant breast reconstruction with postoperative adjuvant radiotherapy.
Visits depending on surgical and radiotherapy schedules
Postoperative Follow-up
Duration - Up to 1 year after surgery for primary and secondary outcomes; oncological safety assessed up to 5 years postoperatively
Participants are followed to assess breast reconstruction outcomes including BREAST-Q scores, complications, aesthetic effects, capsular contracture, nipple and skin sensation, and oncological safety.
Regular visits up to 1 year and long-term monitoring up to 5 years
Trial Site Locations
Total: 1 location
1
Henan cacer hospital
Henan, Henan, China, 450008
Actively Recruiting
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Research Team
X
xiuchun Chen
M
minhao Lv
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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